Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
This study is currently recruiting participants.
Verified April 2013 by Virginia Commonwealth University
Sponsor:
Virginia Commonwealth University
Collaborator:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00580970
First received: December 20, 2007
Last updated: April 23, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: lovastatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- Toxicity to the rectum within the first two years of radiation treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 53 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Lovastatin + radiation therapy
|
Drug: lovastatin
20 mg/day for 12 months
|
Detailed Description:
Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- Planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 Gy). A portion of the rectum must receive at least 60 Gy.
- Age at least 18 years
- Karnofsky Performance Status (KPS) ≥ 70
- No history of prior radiotherapy to the prostate or rectum
- History of prior malignancy, if likely to live at least 4 years, is acceptable.
- No evidence of distant metastases
- Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
- Creatine kinase < 5 times upper normal limit
- Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
- transaminases < 3 times upper normal limit
Exclusion Criteria:
- Planned abdomino-perineal resection after radiotherapy
- Contraindication to an HMG-coA-reductase inhibitor
- Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- Currently taking an inhibitor of cytochrome P450 3A4
- Active liver or muscle disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580970
Contacts
| Contact: Mitchell S. Anscher, MD | 804-828-7238 | msanscher@vcu.edu |
| Contact: Diane J. Holdford, RN | 804-828-0296 | djholdfo@vcu.edu |
Locations
| United States, Virginia | |
| Massey Cancer Center/Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: Mitchell S. Anscher, MD | |
| Hunter Holmes McGuire Veterans Administration Medical Center | Recruiting |
| Richmond, Virginia, United States, 23249 | |
| Contact: Drew Moghanaki, MD 804-675-5850 dmoghanaki@mcvh-vcu.edu | |
| Contact: Vicki Skinner, RN 804-675-5646 vskinne@vcu.edu | |
| Principal Investigator: Michael G. Chang, MD | |
| Southside Regional Medical Center | Active, not recruiting |
| Richmond, Virginia, United States, 23805 | |
Sponsors and Collaborators
Virginia Commonwealth University
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
| Principal Investigator: | Mitchell S. Anscher, MD | Massey Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00580970 History of Changes |
| Other Study ID Numbers: | MCC-10802 |
| Study First Received: | December 20, 2007 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
prostate cancer radiation therapy lovastatin rectal injury |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Lovastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013